Topical Antibiotics in Chronic Rhinosinusitis

Researchers are trying to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Drug: Mupirocin; Drug: Tobramycin; Drug: Levofloxacin; Drug: Vancomycin

Detailed Description

There is a certain group of patients that has chronic rhinosinusitis that has continued even with treatment including saline and steroid nasal irrigations as well as oral steroids and antibiotics and surgery.

In these patients, the use of topical antibiotic nasal rinses may be of benefit to their disease. The use of topical antibiotic nasal rinses is commonly used as standard of care already throughout the country for refractory chronic rhinosinusitis including here at the Mayo Clinic. Our pharmacy has compounded this medication for this specific purpose. As such, this study is not aimed at a 'novel medication', but rather to investigate the efficacy of a medication already in common use but without great evidence.

The investigators are doing this research study to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.

In addition, this study will look at the effects of topical antibiotics on patient symptoms as measured by a patient survey called the Sino-Nasal Outcomes Test (SNOT-22) and in-office an exam of the inside of their nose, including with a scope (a camera on the end of a long tube).

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, between 18-80 years old, diagnosed with chronic rhinosinusitis who have undergone previous functional endoscopic sinus surgery including at minimum maxillary antrostomy and anterior ethmoidectomy
• Active mucopurulence on endoscopic examination with corresponding culture demonstrating pathogenic bacterial growth
• Completion of written informed consent
• No prior enrollment into this study
• Refractory to maximal medical therapy

Exclusion Criteria:

• Patient has not had prior endoscopic sinus surgery consisting of at minimum maxillary antrostomy and anterior ethmoidectomy
• Patient is currently being treated with oral antibiotics
• Patient has been treated with oral or topical antibiotics within the past 14 days
• Participation in an investigational drug study simultaneously with participation in this study
• Concurrent use of oral steroids
• Allergy to Tobramycin, Mupirocin, Gentamicin and Levofloxacin
• Known to currently be pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mupirocin Topical Antibiotic Nasal Saline Rinse; Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.	Drug: Mupirocin; 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
Experimental: Tobramycin Topical Antibiotic Nasal Saline Rinse; Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.	Drug: Tobramycin; 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
Experimental: Levofloxacin Topical Antibiotic Nasal Saline Rinse; Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.	Drug: Levofloxacin; 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
Experimental: Vancomycin Topical Antibiotic Nasal Saline Rinse; Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.	Drug: Vancomycin; 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Who Developed Antibiotic Resistance Organisms	Number of subjects who developed new antibiotic resistance organisms measured by nasal swab of the affected sinonasal cavity and sent for stain, culture, and sensitivity.	Post-intervention (within 21 days of intervention completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey	Scores are measured from 0-5 in a 22-item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms.	Baseline, Post-intervention (within 21 days of intervention completion)
Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores.	Scores are measured on a 0-2 scale for nasal polyps, edema, and secretions in both right and left nasal cavities. Total scores range from 0 to 12 with higher scores indicating greater evidence of sinonasal disease on physical exam.	Baseline, Post-intervention (within 21 days of intervention completion)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Garret W Choby, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Vancomycin; Mupirocin; Levofloxacin; Ofloxacin; Tobramycin
• Other Study ID Numbers: 18-006599

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No